FDA 510(k)

Carex Hybrid Personal Lubricant

Номер K: K223519 · 2023-08-11

Дата решения2023-08-11

Код продуктаNUC

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Carex Hybrid Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Karex Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K223519. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Carex Hybrid Personal Lubricant?

Carex Hybrid Personal Lubricant is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Karex Industries Sdn. Bhd.. The 510(k) number is K223519.

When did Carex Hybrid Personal Lubricant receive FDA 510(k) clearance?

Carex Hybrid Personal Lubricant received FDA 510(k) clearance on 2023-08-11, under 510(k) number K223519.

Who is the listed applicant for Carex Hybrid Personal Lubricant?

The FDA 510(k) record lists Karex Industries Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carex Hybrid Personal Lubricant?

The FDA product code for Carex Hybrid Personal Lubricant is NUC.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NUC)

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLC K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Официальный источник

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